CLASS II Device recall · Reported 2 Sep 2015 · FDA Enforcement Report

Cidex Activated Dialdehyde Solution/case recalled

Advanced Sterilization Products is recalling Cidex Activated Dialdehyde Solution/case, distributed nationwide in the US. The recall was initiated on 27 Jul 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codes210813065 210813066 220813066 230813067 270813067 270813068 270813069 280813069 280813070 290813070 021013082 031013082 031013083 031013084 041013084 071013084 071013085 111013090 111013091 141013091 231013091 241013091 241013092 281013093 060114109 070114109 290114001 300114001 300114002 100214003 100214004 110214004 130214004 010414020 010414021 250314017 260314017 260314018 270314018 270314019 310314019 310314020 070514029 120514029 120514030 130514030 140514030 010714048 300614047 020714048 020714049 030714049 090914066 100914066 110914066 110914067 150914067 160914068 170914068 170914069 021014077 231014084 231014085 271014085 271014086 281014086 201114092 211114092 091214099 091214100 150115006 160115006 220115006 220115007 230115007 100215012 110215012 110215013 050515029 050515030 060515030 070515031

Quantity recalled23,426 cases

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2459-2015
FDA event ID: 71708
Recalling firm: Advanced Sterilization Products, Irvine, CA
Classification: Class II
Status: Terminated
Recall initiated: 27 Jul 2015
FDA classified: 25 Aug 2015
Reported: 2 Sep 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

27 Jul 2015	Recall initiated by company
25 Aug 2015	Classified by FDA	+29 days
2 Sep 2015	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

CIDEX Activated Dialdehyde Solution, 4 bottles/case, P/N: 2266

Where it was distributed

US (nationwide) Distribution

Nationwide

Questions about this recall

Why was it recalled?

Advanced Sterilization Products (ASP) is recalling the CIDEX Activated Dialdehyde Solution because it may lack the adequate data to support the entire 24-month shelf life.

Which lots are affected?

210813065 210813066 220813066 230813067 270813067 270813068 270813069 280813069 280813070 290813070 021013082 031013082 031013083 031013084 041013084 071013084 071013085 111013090 111013091 141013091 231013091 241013091 241013092 281013093 060114109 070114109 290114001 300114001 300114002 100214003 100214004 110214004 130214004 010414020 010414021 250314017 260314017 260314018 270314018 270314019 310314019 310314020 070514029 120514029 120514030 130514030 140514030 010714048 300614047 020714048 020714049 030714049 090914066 100914066 110914066 110914067 150914067 160914068 170914068 170914069 021014077 231014084 231014085 271014085 271014086 281014086 201114092 211114092 091214099 091214100 150115006 160115006 220115006 220115007 230115007 100215012 110215012 110215013 050515029 050515030 060515030 070515031

Where was it sold?

US (nationwide) Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Advanced Sterilization Products

All 36

Reported	Class	Recall	Company	Reason	Where
22 Feb 2017Device	CLASS II	Sterrad NX Sterilization System, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
18 Jan 2017Device	CLASS II	Evotech Endoscope Cleaner and Reprocessor System 208V, Product recalled	Advanced Sterilization Products	Sterility	Nationwide
23 Sep 2015Device	CLASS II	Cidex OPA Solution recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	CA
19 Aug 2015Device	CLASS II	Wall Chart for Sterrad 100NX System recalled by Advanced Sterilization	Advanced Sterilization Products	Sterility	Nationwide
17 Jun 2015Device	CLASS II	Evotech Endoscope Cleaner and Reprocessing System 208V recalled	Advanced Sterilization Products	Sterility	Nationwide

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